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Идёт набор NCT07719699

Effects of Whole-Body Vibration and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain

Без фазы С лечением Chronic Non Specific Low Back Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Whole body vibration, Pilates.
Кому может быть актуально
Состояния в реестре: Chronic Non Specific Low Back Pain. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Whole-Body Vibraton and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain

Обзор

Chronic non-specific low back pain (CNSLBP) affects pain, balance, and functional ability. This randomized clinical trial aims to compare the effects of whole-body vibration (WBV) and Pilates, both combined with conventional physiotherapy, on pain, dynamic balance, and functional performance. A total of 68 participants aged 18-40 years will be randomly assigned to either a WBV group or a Pilates group. Both groups will receive treatment three times per week for four weeks. Outcomes will be measured using the Visual Analog Scale (pain), Y-Balance Test (dynamic balance), and Progressive Isoinertial Lifting Evaluation (functional performance). The results will help determine which intervention is more effective for managing CNSLBP and guide evidence-based rehabilitation practices.

Подробное описание

Chronic non-specific low back pain (CNSLBP) is a highly prevalent musculoskeletal condition that significantly impairs pain levels, dynamic balance, and functional performance, leading to reduced mobility and quality of life. Although various rehabilitation strategies exist, uncertainty remains regarding the comparative effectiveness of different interventions, particularly between active exercise-based approaches and passive modalities.

Pilates is a widely used exercise therapy focusing on core stability, postural control, flexibility, and muscle coordination, and has demonstrated effectiveness in reducing pain and disability in individuals with CNSLBP. Whole-body vibration (WBV), on the other hand, is an emerging rehabilitation modality that utilizes mechanical vibrations to stimulate neuromuscular activation, potentially improving muscle strength, balance, and functional performance. However, most previous studies have combined WBV with exercise, making it difficult to isolate its independent effects.

This randomized clinical trial aims to directly compare the effects of whole-body vibration therapy and Pilates, both combined with conventional physiotherapy, on pain intensity, dynamic balance, and functional performance in patients with chronic non-specific low back pain.

A total of 68 participants aged 18-40 years with CNSLBP will be randomly allocated into two groups. Group A will receive whole-body vibration therapy along with conventional treatment, while Group B will receive Pilates exercises along with conventional treatment. Both interventions will be administered three times per week for four weeks.

Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), dynamic balance assessed using the Y-Balance Test, and functional performance assessed using the Progressive Isoinertial Lifting Evaluation (PILE) test. Assessments will be conducted by a blinded outcome assessor to minimize bias.

The findings of this study will provide high-quality evidence regarding the comparative effectiveness of WBV and Pilates, particularly in relation to dynamic balance, an underexplored but clinically important outcome. This study will help inform evidence-based rehabilitation strategies and guide clinicians in selecting appropriate interventions for individuals with CNSLBP, especially for patients who may have limited tolerance for conventional exercise programs.

Вмешательства

  • Другое Whole body vibration
    Whole-body vibration therapy will be delivered using a side-alternating vibration platform under the supervision of a trained physiotherapist. The intervention will be performed 3 sessions per week for 4 weeks. Each session will last 30 minutes, consisting of 10 bouts of 2 minutes vibration followed by 1 minute rest. Vibration parameters will include a frequency of 18 Hz and an amplitude of 2 mm. Participants will maintain a static standing posture with slight knee flexion, slight lumbar lordos
  • Другое Pilates
    Mat-based Pilates exercises will be performed under the supervision of a trained physiotherapist. The intervention will be conducted 3 sessions per week for 4 weeks, with each session lasting approximately 30 minutes, using a 2:1 work-rest ratio similar to the WBV group. The program will include: Diaphragmatic breathing: 2 min activity + 1 min rest The Hundred: 2 sets of 2 min with 30 sec rest Roll Up: 5 cycles (40 sec activity + 20 sec rest) Single Leg Circles: small and large circles (40 sec

Первичные конечные точки

  • Pain intensity [Срок оценки: Time Frame: Baseline and 4 weeks (post-intervention).]
  • Dynamic Balance [Срок оценки: 4 weeks]
  • Functional performance [Срок оценки: Time Frame: Baseline and 4 weeks (post-intervention).]

Критерии участия

Критерии включения

  • Male and Female (18-40 years age)
  • Pain lasting for more than 12 weeks(determined by patient history)
  • Pain scores (VAS) ranging from 3 to 8 points
  • Pain located between T12 and gluteal folds(determined via palpation)
  • Not having attended Pilates for low back pain for atleast 6 months prior to enrollment

Критерии исключения

  • History of spinal surgery, fractures, tumors, infections, or inflammatory spinal disease.
  • Pregnant or lactating( strongly contraindicated for whole body vibration due to potential fetal risk and pelvic instability)
  • Radicular pain, nerve root compression or neurological deficits.
  • Medical comorbidities (e.g cardiovascular, neurological, endocrine or metabolic disease)(5).
  • Physical limitations (e.g. orthopedic or rheumatic diseases, muscular injury, fibromyalgia, or pain)that could affect their ability to perform the Pilate exercises.
  • Participants whose weight exceeds 150kg ( that's the maximum weight bearing capacity for WBV)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Surraya Azeem waqf hospital — Lahore

Идентификаторы

NCT: NCT07719699 · UBAS/ERB/26/04/014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗